Actively Recruiting
Post-Operative Cognitive Dysfunction After Breast Surgery: Incidence and Relation With Common Intraoperative Neuromonitoring Data and Concentration of Propofol and Remifentanil Infused With Targeted Controlled Infusion (TCI) in Women With Laryngeal Mask Airway
Led by University of Padova · Updated on 2026-04-21
200
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates Post-Operative Cognitive Dysfunction (POCD) and Postoperative Delirium in women undergoing breast surgery under general anesthesia. It aims to understand whether changes in neurocognitive test results before and after surgery relate to drug concentrations and common monitoring values during surgery. The study focuses on anesthesia delivered with targeted-controlled infusion of propofol and remifentanil and uses a laryngeal mask airway for airway management. Participants receive general anesthesia using propofol and remifentanil administered via targeted-controlled infusion, with the airway managed by a laryngeal mask. Researchers will monitor common intraoperative neuromonitoring values such as Bispectral Index, Entropy monitoring, and Surgical Plethysmographic Index, along with pupillometry measures including pupil diameter, latency, and maximum contraction velocity. The study observes neurocognitive functions and delirium occurrences linked to these anesthesia and monitoring parameters. Women enrolled will undergo several cognitive assessments before surgery and after awakening. These include the Montreal Cognitive Assessment, Trail Making Tests A and B, Digit Span Test, Confusion Assessment Method, Short Portable Mental Status Questionnaire, Mini-Mental State Evaluation, and the 4AT test. Evaluations occur one day before and within an hour to one day after surgery. The study tracks the incidence of cognitive dysfunction and delirium, aiming to correlate these outcomes with anesthesia drug levels and monitoring data over the study duration ending in 2027.
CONDITIONS
Brief Title
Post Operative Cognitive Dysfunction After Breast Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- General Anaesthesia delivered with Propofol and Remifentanil with Targeted Controlled Infusion
- Use of Laryngeal Mask airway
- Female participants
- Age 18 years or older
You will not qualify if you...
- Neurological pathologies
- Haemodynamical instability during surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo breast surgery under general anesthesia with Targeted Controlled Infusion and Laryngeal Mask Airway. Cognitive assessments and delirium evaluations occur shortly after surgery.
1 surgery day visit and assessments within 1 hour and 1 day after surgery
Duration - 2 days
Participants complete additional cognitive function tests one day before and one day after surgery to assess post-operative cognitive dysfunction.
2 visits: 1 visit one day before surgery and 1 visit one day after surgery
Trial Site Locations
Total: 1 location
1
Treviso Regional Hospital
Treviso, TV, Italy, 31100
Actively Recruiting
Research Team
F
Federico Linassi, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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